Effects of a probiotic product containing Bifidobacterium animalis subsp. animalis IM386 and Lactobacillus plantarum MP2026 in lactose intolerant individuals: Randomized, placebo-controlled clinical trial

- Patients in probiotic and placebo group reported improvement in LI-symptoms.
- Beneficial effect of probiotic product over placebo was not demonstrated.
- High placebo effect and variability in symptoms/breath test results were observed.
- Probiotic product tended to have a significant lowering effect on diarrhoea.
- Results suggest subject-specific effects of the probiotic product in LI-patients.

The data on the efficacy of probiotics in lactose intolerance (LI) management are limited, and clinical trials are lacking. The aim of this study was to assess the efficacy of a probiotic product in LI individuals. Altogether, 44 patients (test = 22, placebo = 22) were randomized and the probiotic product or placebo was administered for 6 weeks. LI symptoms trended towards improvement in both groups with no significant differences in between groups suggesting a strong placebo effect in symptoms severity perception. Comparing baseline scores with the scores after the supplementation and 2 weeks follow-up period within groups, the consumption of the probiotic product tended to have a significant lowering effect on diarrhoea and flatulence (p < 0.05), respectively. No adverse reports and detected efficacy trends suggest administration of the probiotic product as possible approach in LI symptoms alleviation but study with more participants is necessary because of great variability among individuals.